DICLOFENAC SODIUM solution/ drops DICLOFENAC SODIUM solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Saadav alates:

DIRECT RX

Manustamisviis:

TRANSDERMAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). Diclofenac sodium topical solution is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of diclofenac sodium topical solution. Diclofenac sodium topical solution is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see WARNINGS AND PRECAUTIONS (5.7, 5.10)]. Diclofenac sodium topical solution is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS (5.1)]. 8.1 Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Teratogenic Effects: There are no adequate and well-controlled studies of diclofenac sodium topical sol

Toote kokkuvõte:

Diclofenac Sodium Topical Solution is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density polyethylene bottle with a white low-density dropper cap.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION/ DROPS
DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
DIRECT RX
----------
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death.
This chance increases:
with longer use of NSAID medicines
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
can happen without warning symptoms
may cause death
The chance of a person getting an ulcer or bleeding increases with:
taking medicines called "corticosteroids" and "anticoagulants" longer
use
smoking drinking
alcohol older
age
having poor health
NSAID medicines should only be used:
exactly as prescribed
at the lowest dose possible for your treatment
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as:
different types of arthritis
menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID medicine
for pain right before or after heart bypass surgery
Tell your healthcare provider:
about all of your medical conditions.
about all of the medicines you take. NSAIDs and some other medicines
can interact with each other and
cause serious side effects. Keep a list of your medicines to show to
your healthcare provider and
pharmacist.
if you are pregnant, NSAID medicines should not be used by pregnant
women late in their pregnancy.
if you are b

Toote omadused

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION/ DROPS
DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
DIRECT RX
----------
DICLOFENAC SODIUM TOPICAL SOLUTION
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
Cardiovascular Risk
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased
risk of serious
cardiovascular thrombotic events, myocardial infarction, and stroke,
which can be fatal. This risk
may increase with duration of use. Patients with cardiovascular
disease or risk factors for
cardiovascular disease may be at greater risk [see WARNINGS AND
PRECAUTIONS (5.1)].
Diclofenac sodium topical solution is contraindicated in the
perioperative setting of coronary
artery bypass graft (CABG) surgery [see CONTRAINDICATIONS (4)].
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including bleeding,
ulceration, and perforation of the stomach or intestines, which can be
fatal. These events can
occur at any time during use and without warning symptoms. Elderly
patients are at greater risk for
serious gastrointestinal events [see WARNINGS AND PRECAUTIONS (5.2)].
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory
drug (NSAID) indicated for the
treatment of signs and symptoms of osteoarthritis of the knee(s).
2.1 General Instructions
For the relief of the signs and symptoms of osteoarthritis of the
knee(s), the recommended dose is 40
drops per knee, 4 times a day.
Apply diclofenac sodium topical solution to clean, dry skin.
To avoid spillage, dispense diclofenac sodium topical solution 10
drops at a time either directly onto
the knee or first into the hand and then onto the knee. Spread
diclofenac sodium topical solution evenly
around front, back and sides of the knee. Repeat this procedure until
40 drops have been applied and the
knee is completely covered with solution.
To treat the other knee, if symptomatic, repeat the procedure.
Application of diclofenac sodium topical solution in an amount
exceeding or less than the recommended
dose has not bee